1. Field of the Invention
This invention relates to surgical drapes; more particularly, to multi-element drapes that can be separated after use into contaminated and non-contaminated elements.
2. Description of the Related Art
Surgical drapes are used to maintain a sterile field in the vicinity of a surgical site, in order to prevent infection or contamination. In the process of use, a surgical drape becomes contaminated with blood and other body fluids. The contaminated drapes must be carefully segregated, so that they do not spread pathogens into the environment. Used disposable drapes must be "red-bagged;" i.e., maintained separately from non-contaminated waste. With the increasing concern regarding the potential environmental and waste disposal problems posed by contaminated medical waste, disposing of red-bag waste in an acceptable manner is becoming increasingly expensive. There is thus an incentive to reduce the amount of contaminated waste generated by surgical procedures (See, e.g., Tieszen ME and Gruenberg JC, "A Quantitative, Qualitative, and Critical Assessment of Surgical Waste," JAMA 267, 2765 [May 27, 1992]).
A number of patents disclose inventions that relate to the present invention. U.S. Pat. No. 4,024,862, issued on May 24, 1977, to R.F. Colins, discloses a drape that includes auxiliary elements. Specifically, a conventional surgical drape includes a fenestration that is large enough to perform an enlarged surgical procedure, but the fenestration is covered by one or more "frame sheets" removably secured to the upper surface of the drape around the fenestration. The frame sheet has a smaller fenestration aligned with the large fenestration in the drape. Thus a reduced surgical procedure may be performed through the fenestration of the frame sheet or, alternatively, the frame sheet can be removed in order to perform the enlarged procedure.
U.S. Pat. Nos., 4,316,455 and 4,316,456, issued on Feb. 23, 1982, to W.K. Stoneback, disclose a draping system designed to reduce the inventory that a hospital must stock. The system makes use first of a small drape that is placed in contact with the patient and that includes a fenestration for placement over the operative site. Thereafter, a large "standardized" top sheet is placed over the bottom drape. The larger top drape, which has a fenestration that is larger than that of the bottom drape but smaller than the outer periphery of the bottom drape, is positioned so that the fenestrations are aligned. The top drape is then secured to the bottom drape.
U.S. Pat. No. 4,476,860, issued on Oct. 16, 1984, to R.F. Collins, discloses a drape comprising a main sheet that has adhered to its top surface (away from the patient) a transparent sheet, which includes pockets for holding instruments and collecting body fluids, and a reinforcement sheet. A fenestration extends through the main sheet, transparent sheet, and reinforcement sheet.
U.S. Pat. No. 5,074,316, issued on Dec. 24, 1991, to R. C. Dowdy, discloses a drape for brachial angiography and an instrument pouch that may be secured removably to the drape near the surgical site.
Surgical drapes are known that include fluid-collection pouches near a fenestration for collecting fluids generated during the surgical procedure. Such drapes are available, for example, from Neuromedics, Inc., Sugar Land, Tex. and Alcon Surgical, Fort Worth, Tex. The pouches on these drapes have no provision for closing them after use to prevent leakage.
None of these patents suggest a multi-element drape that permits a separation of contaminated from non-contaminated elements after use. Nor do drapes of the prior art suggest such multi-element drapes.